Recall Register

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Integra LifeSciences Corp. d.b.a. Integra Pain Management

FDA recalling firm · 10 enforcement events · 10 product records · 2012–2016 · UT

Integra LifeSciences Corp. d.b.a. Integra Pain Management has 10 FDA enforcement events on this register (10 product records) between 2012 and 2016: 10 device; the busiest year was 2013 with 3.

0% of its events are Class I; the most common class is Class II (9). 0 events are listed as ongoing; the recalling firm's address is in UT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
24 Aug 2016PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.DeviceClass II1Terminated
24 Aug 2016Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHNDDeviceClass II1Terminated
4 Aug 2016INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.DeviceClass II1Terminated
22 Sep 2015Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed…DeviceClass II1Terminated
1 May 2015Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed…DeviceClass II1Terminated
30 Mar 2015Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.DeviceClass II1Terminated
26 Nov 2013Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial…DeviceClass II1Terminated
28 Oct 2013Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of…DeviceClass II1Terminated
4 Sep 2013Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP),…DeviceClass II1Terminated
7 Jun 2012Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644.…DeviceClass III1Terminated

By type and class

Device10
Class II9
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Integra LifeSciences Corp. d.b.a. Integra Pain Management by year initiated.

Questions and answers

How many FDA recalls has Integra LifeSciences Corp. d.b.a. Integra Pain Management had?

10 enforcement events (10 product records) on this register, 2012–2016: 10 device.

Are any Integra LifeSciences Corp. d.b.a. Integra Pain Management recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Integra LifeSciences Corp. d.b.a. Integra Pain Management recalls?

9 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.